Clinical Research Associate II – Phase I (On-Site Monitoring)
Location: Dallas, Texas, United States
Category: Clinical Operations
Job ID: 2649
Employment Type: Full-Time
Experience Required: Minimum 2+ Years Clinical Monitoring Experience
Compensation: Target Pay Range USD 100,000 – 113,000 per year
About the Company
Fortrea is a global contract research organization (CRO) delivering clinical development and clinical pharmacology services to pharmaceutical, biotechnology, and medical device companies. The Clinical Pharmacology Team supports early-phase studies with rigorous compliance, patient safety oversight, and data integrity standards.
Position Overview
Fortrea is seeking an experienced Clinical Research Associate II (CRA II) with Phase I clinical trial monitoring experience to support early-phase studies in Dallas, Texas.
The CRA II will apply clinical expertise and regulatory knowledge to ensure participant safety, protocol adherence, and data accuracy in fast-paced Phase I research environments.
Key Responsibilities
Clinical Site Monitoring & Management
Perform routine monitoring visits, pre-study visits, site initiation visits, and close-out visits
Oversee all aspects of site management according to approved project plans
Maintain study files and essential documentation in compliance with GCP and regulatory requirements
Liaise with vendors and cross-functional stakeholders
Participant Safety & Regulatory Compliance
Ensure proper informed consent procedures are followed
Verify adherence to protocol requirements and regulatory guidelines
Protect study participants by maintaining high clinical standards
Complete Serious Adverse Event (SAE) reporting, narrative preparation, and follow-up activities
Data Integrity & Quality Oversight
Conduct source document verification (SDV)
Review Case Report Forms (CRFs) for accuracy and completeness
Identify missing or inconsistent data and generate queries
Independently perform CRF review and query resolution within sponsor or CRO data systems
Project Coordination & Collaboration
Support registry management activities
Conduct feasibility assessments when required
Assist in training new CRAs through co-monitoring
Serve as Local Project Coordinator when assigned
Act as local client contact under supervision
Required Qualifications
University degree or certification in an allied health profession (e.g., Nursing or equivalent accredited qualification)
Minimum 2+ years of clinical monitoring experience
Phase I clinical trial experience preferred
Comfortable performing 10–12 Days On Site (DOS) per month
Must reside in the Dallas, Texas area
Work Environment Expectations
Fast-paced Phase I clinical setting with strict protocol adherence
Dynamic priorities requiring adaptability and strong organizational skills
Team-oriented environment emphasizing collaboration and communication
Technology-driven clinical operations using electronic data capture (EDC) systems
Core Competencies
Strong understanding of Good Clinical Practice (GCP)
Knowledge of clinical trial regulatory requirements
Excellent attention to detail and documentation accuracy
Strong communication and teamwork skills
Ability to manage timelines in high-compliance environments
Compensation & Benefits
Eligible full-time or part-time employees (20+ hours per week) may receive comprehensive benefits including:
Medical, Dental, Vision, Life Insurance, STD/LTD
401(k) Retirement Plan
Paid Time Off (PTO) – Flex Plan
Employee Recognition Programs
Employee Resource Groups (ERGs)
Application Information
Applications are accepted on an ongoing basis.
SEO Keywords:
Clinical Research Associate II Dallas, Phase I CRA jobs Texas, Clinical Monitoring jobs Dallas, Early Phase Clinical Trials CRA, GCP monitoring careers USA, CRO CRA II vacancy, Phase I clinical research jobs Texas.
Explore more global clinical research and CRO career opportunities at ThePharmaDaily.com.
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